Systems and methods for evaluating cardiac therapy

• US 9,586,052 B2
• Filed: 05/04/2015
• Issued: 03/07/2017
• Est. Priority Date: 08/15/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gillberg, Jeffrey, Ghosh, Subham, Haddad, Tarek
• Primary Examiner(s): Getzow, Scott
• Application Number:
  US14/703,412
• Publication Number:
  US 20160045744A1
• Time in Patent Office: 673 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems and methods are described herein for assisting a user in evaluation of cardiac therapy. The systems and methods may monitor electrical activity of a patient using external electrode apparatus to provide baseline electrical heterogeneity information and therapy electrical heterogeneity information. The electrical heterogeneity information may be used to generate surrogate hemodynamic information.

Claims

1. A system for use in evaluation of cardiac therapy comprising:

electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient, wherein the plurality of electrodes comprises two or more left external electrodes configured to be located proximate the left side of the patient; and

computing apparatus coupled to the electrode apparatus and configured to;

monitor baseline electrical activity using the plurality of external electrodes,

monitor therapy electrical activity using the plurality of external electrodes during delivery of pacing therapy using a selected pacing configuration,

generate electrical heterogeneity information representative of at least one of mechanical cardiac functionality and electrical cardiac functionality for each of the baseline electrical activity and the therapy electrical activity, wherein the electrical heterogeneity information comprises;

a global metric based on the electrical activity monitored by the plurality of external electrodes, and

at least one local metric based on the electrical activity monitored by the two or more left external electrodes, and

generate surrogate hemodynamic response information representative of the hemodynamic response to the pacing therapy delivered using the selected pacing configuration based on the electrical heterogeneity information for each of the baseline electrical activity and the therapy electrical activity.

2. The system of claim 1, wherein generating surrogate hemodynamic response information representative of the hemodynamic response to the pacing therapy delivered using the selected pacing configuration based on the electrical heterogeneity information for each of the baseline electrical activity and the therapy electrical activity comprises:

providing a transfer function configured to receive the global metric and the at least one local metric to generate surrogate hemodynamic response information correlating to left ventricular contractility, wherein the transfer function provides a coefficient of determination (R²) between the surrogate hemodynamic response information and the left ventricular contractility that is greater than or equal to 60%;

inputting the global metric and the at least one local metric into the transfer function; and

generating the hemodynamic response information correlating to left ventricular contractility using the transfer function based on the global metric and the at least one local metric.

3. The system of claim 1, wherein the pacing therapy is delivered by at least one implantable electrode coupled to at least one lead, wherein the hemodynamic response information is configured to assist a user in non-invasively selecting an implant location for the at least one implantable electrode coupled to the at least one lead.

4. The system of claim 1, wherein the at least one local metric comprises at least one of a left standard deviation of surrogate electrical activation times monitored by the two or more left external electrodes and a left average of surrogate electrical activation times monitored by the two or more left external electrodes.

5. The system of claim 1, wherein the global metric comprises a global standard deviation of surrogate electrical activation times monitored by the plurality of external electrodes.

6. The system of claim 1, wherein the selected pacing configuration comprises one or more pacing settings, wherein the one or more pacing settings comprise one or more of A-V intervals, V-V intervals, pacing vectors, pacing energy outputs, pacing locations, and multipoint pacing timings.

7. The system of claim 6, wherein the pacing vector comprises a multipoint pacing vector.

8. The system of claim 1, wherein the selected pacing configuration comprises cathode location.

9. The system of claim 1, wherein the hemodynamic response information comprises a hemodynamic response value representative of the hemodynamic improvement due to the pacing therapy delivered using the selected pacing configuration.

10. The system of claim 9, wherein the computing apparatus is further configured to determine whether the pacing therapy using the pacing configuration is acceptable if the hemodynamic response value is greater than or equal to a threshold value.

11. The system of claim 1, wherein the plurality of external electrodes comprises surface electrodes positioned in an array configured to be located proximate the skin of the torso of the patient.

12. The system of claim 1, wherein the system further comprises display apparatus, wherein the display apparatus comprises a graphical user interface configured to present information for use in assisting a user in evaluating cardiac pacing location,

wherein the computing apparatus is further configured to display the hemodynamic response information on the graphical user interface.

13. The system of claim 12, wherein the computing apparatus is further configured to display a graphical representation of the hemodynamic response information.

14. A method for use in evaluation of cardiac therapy comprising:

providing electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient, wherein the plurality of electrodes comprises two or more left external electrodes configured to be located proximate the left side of the patient;

monitoring baseline electrical activity using the plurality of external electrodes;

monitoring therapy electrical activity using the plurality of external electrodes during delivery of pacing therapy using a selected pacing configuration;

generating electrical heterogeneity information representative of at least one of mechanical cardiac functionality and electrical cardiac functionality for each of the baseline electrical activity and the therapy electrical activity, wherein the electrical heterogeneity information comprises;

a global metric based on the electrical activity monitored by the plurality of external electrodes, and

at least one local metric based on the electrical activity monitored by the two or more left external electrodes; and

generating surrogate hemodynamic response information representative of the hemodynamic response to the pacing therapy delivered using the selected pacing configuration based on the electrical heterogeneity information for each of the baseline electrical activity and the therapy electrical activity.

15. The method of claim 14, wherein generating surrogate hemodynamic response information representative of the hemodynamic response to the pacing therapy delivered using the selected pacing configuration based on the electrical heterogeneity information for each of the baseline electrical activity and the therapy electrical activity comprises:

providing a transfer function configured to receive the global metric and the at least one local metric to generate surrogate hemodynamic response information correlating to left ventricular contractility, wherein the transfer function provides a coefficient of determination (R²) between the surrogate hemodynamic response information and the left ventricular contractility that is greater than or equal to 60%;

inputting the global metric and the at least one local metric into the transfer function; and

generating the hemodynamic response information correlating to left ventricular contractility using the transfer function based on the global metric and the at least one local metric.

16. The method of claim 14, wherein the pacing therapy is delivered by at least one implantable electrode coupled to at least one lead, wherein the hemodynamic response information is configured to assist a user in non-invasively selecting an implant location for the at least one implantable electrode coupled to the at least one lead.

17. The method of claim 14, wherein the at least one local metric comprises at least one of a left standard deviation of surrogate electrical activation times monitored by the two or more left external electrodes and a left average of surrogate electrical activation times monitored by the two or more left external electrodes.

18. The method of claim 14, wherein the global metric comprises a global standard deviation of surrogate electrical activation times monitored by the plurality of external electrodes.

19. The method of claim 14, wherein the selected pacing configuration comprises one or more pacing settings, wherein the one or more pacing settings comprise one or more of A-V intervals, V-V intervals, pacing vectors, pacing energy outputs, pacing locations, and multipoint pacing timings.

20. The system of claim 19, wherein the pacing vector comprises a multipoint pacing vector.

21. The method of claim 14, wherein the selected pacing configuration comprises cathode location.

22. The method of claim 14, wherein the hemodynamic response information comprises a hemodynamic response value representative of the hemodynamic improvement due to the pacing therapy delivered using the selected pacing configuration.

23. The system of claim 22, wherein the method further comprises determining whether the pacing therapy using the pacing configuration is acceptable if the hemodynamic response value is greater than or equal to a threshold value.

24. The method of claim 14, wherein the plurality of external electrodes comprises surface electrodes positioned in an array configured to be located proximate the skin of the torso of the patient.

25. The method of claim 14, wherein the method further comprises displaying the hemodynamic response information on a graphical user interface configured to present information for use in assisting a user in evaluating cardiac pacing location.

26. The method of claim 25, wherein the method further comprises displaying a graphical representation of the hemodynamic response information.